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© 2004 European Association of Cardio-Thoracic Surgery
Is prophylactic administration of steroids of benefit to children undergoing cardiac surgery?Department of Cardiothoracic Surgery, Freeman Hospital, Freeman Road, Newcastle upon Tyne NE7 7DN, UK
* Corresponding authors. Tel.: +44-780-15-48-122; fax: +44-780-1548-122 joeldunning{at}doctors.org.uk Received April 2, 2004; accepted April 6, 2004
A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether prophylactic administration of steroids is of benefit to children undergoing cardiac surgery? Altogether 302 papers were found using the reported search, of which six represented the best evidence. The author, journal, date and country of publication, patient group studied, study type, relevant outcomes, results, and study weaknesses were tabulated. We conclude that steroids may reduce Troponin I release, CRP and reduce Interleukin-6. In addition, two studies, each in only 30 patients, found some evidence for improvements in clinical parameters such as ICU stay and fluid requirement. These findings need confirmation prior to any firm recommendations as to the clinical benefits of steroids.
Key Words: Evidence-based medicine; Steroids; Review; Child; Thoracic surgery; Cardiopulmonary pass
A best evidence topic was constructed according to a structured protocol. This protocol is fully described in the ICVTS [1].
You are about to perform an arterial switch procedure on a 3 kg girl. You ask your anaesthetist to give her 3 mg of dexamethasone on induction of anaesthesia. This anaesthetist has just come from another institution, where this was never done and regarded as even possibly being dangerous. He asks you why you give steroids to all your children undergoing prolonged cardiopulmonary bypass. You quote an animal study that you were involved with as a registrar but you cannot recall any convincing clinical trials, so you resolve to search the literature that evening.
In [children undergoing cardiac surgery] is the use of [prophylactic steroids] of benefit in terms of [attenuated inflammatory response or clinical benefit]?
Medline 1966–March 2004 using the OVID interface [exp steroids/ OR steroid$.mp OR prednisolone.mp OR methylprednisolone.mp OR corticosteroid$.mp OR hydrocortisone.mp OR dexamethasone.mp] AND [exp cardiac surgical procedures/ OR cardiac surgery.mp OR exp cardiovascular surgical procedures/ OR cardiac operation$.mp OR exp cardiopulmonary bypass/ OR cardiopulmonary bypass.mp OR exp Transposition of Great Vessels/ OR exp Heart septal defects, atrial/ OR heart septal defects, ventricular/ OR VSD.mp] AND [Maximally sensitive paediatric search filter] AND [Maximally sensitive RCT filter] Limit to Human.
From 302 papers, of which, six prospective randomized controlled trials (PRCTs) in children were found comparing steroids to either differing regimes of steroid or placebo. These are summarised in Table 1.
Several randomized controlled trials were found examining various regimes of steroid therapy in children undergoing congenital cardiac surgery, although their patient numbers were small and all studies were from single centres. Checchia et al. [2] performed a 28-patient PRCT with Troponin I as the primary outcome measure. They found a significantly increased TnI in the placebo group, and inferred that, therefore, myocardial damage was attenuated by steroids. Mott et al. [3] performed the largest randomized double blind PRCT with 246 children. They used Post Pericardotomy Syndrome (PPS) as their primary outcome measure and found that there was no difference in uncomplicated PPS. However, they found that eight patients treated with methylprednisolone had complicated PPS compared to only one in the control group and concluded that steroids may actually be harmful. Unfortunately this group did not report any biochemical or other clinical markers.
Bronicki et al. [4] conducted a double blind PRCT on 29 children. They provided the most comprehensive findings in support of dexamethasone at 1 mg/kg. They found a significant improvement in ventilation, ICU stay, arterial–alveolar oxygenation, post-operative temperature, and reductions in levels of Interleukin-6. No significant difference was found in TNF- Lindberg et al. [5] performed a PRCT on 40 children comparing dexamethasone 1 mg/kg to placebo. Although CRP was found to be significantly lower on day 1, no other differences were found in other biochemical markers or with any clinical markers, including days in ICU or ventilation time. Two studies compared difference steroid regimes: Varan et al [6] performed a study to see if there was a difference between giving methylprednisolone at 30 and 2 mg/kg. They found no significant differences in clinical parameters, or in IL-6, IL-8, or CRP. Unfortunately this was a very small study with no sample size calculations and thus, this study is likely to have been too small to confidently exclude a difference in these treatments. Schroeder et al. [7] recently performed a 29 patient PRCT to compare pre-operative and intra-operative steroids against the use/administration of intra-operative steroids alone. They found that adding a pre-operative dose resulted in lower fluid requirement, lower body temperature, lower inflammatory marker expression and an almost significant lower ICU stay. It must be noted that the mean age of the group who did not receive pre-operative steroids was half of those who received pre-operative steroids. The studies summarised here do provide some evidence for a benefit in giving steroids, but two studies reported negative findings and the largest study found an increase in complicated post-pericardotomy syndrome with steroids. We were surprised not to find any large prospective or retrospective cohort studies that might have shed further light on the possible changes in clinical course secondary to steroids, and we conclude that there is certainly a great need for further clinical studies in this area, which would optimally be by multi-centre PRCT but even a retrospective cohort study would be highly informative.
Steroids may reduce Troponin I release, CRP and reduce Interleukin-6. In addition two studies, each in only 30 patients, found some evidence for improvements in clinical parameters such as ICU stay and fluid requirement. These findings need confirmation prior to any firm recommendations as to the benefits of steroids. doi:10.1016/j.icvts.2004.04.001
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Abstract
1. Introduction
or complement C3a. It should be noted that this is also a small study and that the steroid group had a mean CPB time of 21 min less than the control group and a crossclamp time 14 min shorter than the control group.